Implantable tissue fastener and system for treating gastroesophageal reflux disease

ABSTRACT

A system including an implantable fastener for fastening layers of tissue is disclosed. In one embodiment, the fastener includes a proximal anchor member and a distal anchor member each being movable from a reduced profile position to a deployed position. The anchor members are mesh structures capable of moving to the deployed position by reducing the axial spacing between opposite ends of the anchor members.  
     Methods of treating gastroesophageal reflux disease (GERD) are also disclosed. One of the methods includes placing the distal anchor member through a hole formed in the wall of the esophagus and through a hole formed in the gastric wall. The distal anchor member and the proximal anchor member are then placed in their deployed positions to fasten the wall of the esophagus and the gastric wall together between the anchor members.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to an implantable tissue fastenerfor fastening layers of tissue together. More particularly, the presentinvention relates to a system and method for fastening of the wall ofthe esophagus and the gastric wall together to treat gastroesophagealreflux disease (GERD).

[0003] 2. Description of Related Art

[0004] The lower esophageal sphincter is located in a distal portion ofthe esophagus adjacent to the junction between the esophagus and thestomach. When food is digested, a properly functioning lower esophagealsphincter allows food to pass from the esophagus to the stomach whilelimiting reverse flow of the stomach contents into the esophagus.

[0005] Gastroesophageal reflux disease (GERD) is a disorder in which thelower esophageal sphincter allows contents of the stomach includinggastric acid and bile to reverse flow into the distal portion of theesophagus during digestion. Complications associated with GERD includeheartburn, pulmonary disorders, chest pain, esophageal ulcers,esophagitis, Barrett's esophagus, and esophageal carcinoma.

[0006] A common treatment for GERD includes administering prescriptionacid blockers for limiting gastric production of acid. Although thesedrugs may provide short term relief, the drugs merely alleviate some ofthe symptoms of GERD rather than correcting the underlying dysfunctionof the lower esophageal sphincter. In addition, acid blockers areexpensive, and any long term complications associated with using acidblockers are unknown.

[0007] Various surgical procedures have been attempted to correct GERD.In one surgical procedure, known as Nissen fundoplication, a portion ofthe gastric fundus is wrapped around the esophagus. The wrapped gastricfundus applies pressure to the esophagus to limit reverse flow of thestomach contents into the esophagus. Conventional fundoplicationprocedures are effective at treating GERD, but they have a number ofdisadvantages. Open procedures require a large incision to expose thestomach and the lower esophagus. In laparoscopic procedures, four orfive smaller incisions are formed in the abdominal wall to insertinstruments into the body of the patient. However, such procedures areexpensive and sometimes require a significant amount of time for patientrecovery.

[0008] Some other procedures, such as those disclosed in U.S. Pat. No.5,403,326 and in U.S. Pat. No. 5,571,116, use surgical staples to securethe fundus of the stomach and the lower esophagus. However, thesestaples have relatively small cross sectional sizes which concentratestresses and could allow for tearing or cutting of tissue. In addition,some of the relatively rigid stapling instruments used in theseprocedures may damage tissue when they are moved in a patient. Also,such rigid instruments are inserted into the operative field with trocartype devices which make abdominal wall penetrations. These abdominalwall penetrations increase the risks of post-operative hernias,accidental organ perforations, or other drawbacks associated withlaparoscopic surgery.

[0009] In light of the foregoing, there is a need in the art for animproved fastener and procedure for treating GERD.

SUMMARY OF THE INVENTION

[0010] Accordingly, the present invention is directed to a fastener,system, and method that substantially obviate one or more of thelimitations of the related art. To achieve these and other advantagesand in accordance with the purpose of the invention, as embodied andbroadly described herein, the invention includes an implantable fastenerfor fastening layers of tissue together. The fastener includes anelongated support and a distal anchor member having a first end portionconnected to the support and a second end portion movable on thesupport. The distal anchor member is configured to be movable from areduced profile position to a deployed position when a spacing betweenthe first and second end portions is reduced. The fastener also includesa proximal anchor member having first and second end portions movable onthe support. The proximal anchor member is configured to be movable froma reduced profile position to a deployed position when a spacing betweenthe first and second end portions of the proximal anchor member isreduced, and the proximal anchor member is spaced from the distal anchormember a distance sufficient to position the layers of tissue togetherbetween the proximal and distal anchor members. At least one retainer isprovided on a proximal end portion of the support. The retainer engagesone of the end portions of the proximal anchor member when at least theproximal anchor member is in the deployed position.

[0011] In another aspect, the fastener includes a first anchor member, asecond anchor member, and a connecting section connecting the proximalend portion of the first anchor member to the distal end portion of thesecond anchor member. An elongated support is connected to the distalend portion of the first anchor member. The support is movableproximally in the second end portion of the distal anchor member, in theconnecting section, and in the second anchor member to place the firstand second anchor members in the deployed positions.

[0012] In another aspect, the fastener includes an inflatable balloonand a cap member.

[0013] In a further aspect, a system for fastening tissue is provided.The system includes the fastener and structure for inserting and/ordeploying the fastener.

[0014] In yet another aspect, the present invention includes a method oftreating gastroesophageal reflux disease. In the method, the implantablefastener is passed transorally through the esophagus to a position nearthe junction between the esophagus and the stomach. The distal anchormember is inserted through a hole formed in the wall of the esophagusand through a hole formed in the gastric wall while the distal anchormember is in the reduced profile position. Both the distal anchor memberand the proximal anchor member are placed in the deployed positions tofasten the wall of the esophagus and the gastric wall together betweenthe deployed distal anchor member and the deployed proximal anchormember.

[0015] In a further aspect, the method according to the inventionincludes inflating a balloon in the stomach and placing a cap memberagainst the esophageal wall.

[0016] In another aspect, the invention includes a method of fasteningat least two layers of tissue together. This method comprisesintroducing an adhesion inducing agent between first and second tissuelayers of a body, inserting an implantable fastener in the body, andholding the first and second tissue layers together with the implantablefastener while the adhesion inducing agent is between the first andsecond tissue layers.

[0017] It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary, andare intended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The accompanying drawings are included to provide a furtherunderstanding of the invention and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments of theinvention and, together with the description, serve to explain theprinciples of the invention. In the drawings,

[0019]FIG. 1 is view of a distal end portion of a tissue fasteningsystem according to a first embodiment of the invention;

[0020]FIG. 2 is a view of a proximal end portion of the tissue fasteningsystem of FIG. 1;

[0021]FIG. 3 is a view similar to FIG. 1 showing a tissue fastener ofthe system extending from an introducer tube;

[0022]FIG. 4 is a view similar to FIG. 2 showing the connection of theintroducer tube and pusher tube when the introducer extends from theintroducer tube as shown in FIG. 3;

[0023]FIG. 5 is a schematic view showing the fastener and portion of anactuator of the system of FIG. 1;

[0024]FIG. 6 is view similar to FIG. 3 showing deployment of anchormembers on the fastener;

[0025]FIG. 7 is a view similar to FIG. 6 showing the introducer andpusher tube being withdrawn from the fastener after the anchor membersare deployed;

[0026]FIG. 8 is a schematic view showing how the fastener of the systemof FIGS. 1-7 fastens layers of body tissue when the anchor members aredeployed;

[0027]FIG. 9 is a schematic view of a distal end portion of a tissuefastening system according to a second embodiment of the invention;

[0028]FIG. 10 is a schematic view of the system of FIG. 9 showing how aproximal anchor member is deployed after a distal anchor member isdeployed;

[0029]FIG. 11 is a view similar to FIG. 9 of a third embodiment of theinvention;

[0030]FIG. 12 is a view showing how the system initially forms a hole inthe wall of the esophagus and a hole in the gastric wall during a GERDtreatment procedure;

[0031]FIG. 13 is a view showing deployment of the distal anchor memberin the stomach to anchor the fastener to the gastric wall;

[0032]FIG. 14 is a view showing deployment of distal and proximal anchormembers to secure the wall of the esophagus to the gastric wall;

[0033]FIG. 15 is a view similar to FIG. 12 showing a tissue grasper andendoscope for use in forming the holes in the esophageal wall andgastric wall;

[0034]FIG. 16 is a partially exploded, side view of an embodiment of afastener having an inflatable balloon and cap member;

[0035]FIG. 17 is a view similar to FIG. 12 showing how holes are formedin the esophageal wall and gastric wall during use of the fastener ofFIG. 16 in a GERD treatment procedure;

[0036]FIG. 18 shows how the balloon of FIG. 16 is inflated;

[0037]FIG. 19 shows how the cap member of FIG. 16 is pushed toward thefastener of FIG. 16; and

[0038]FIG. 20 is a view similar to FIG. 14 showing the fastener of FIG.16.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numbers areused in the drawings and the description to refer to the same or likeparts, and similar reference numerals are used to refer to similarelements.

[0040] FIGS. 1-7 show a tissue fastening system 10 according to a firstembodiment of the invention. As shown in FIGS. 1, 3, and 5-7, the system10 includes an implantable fastener 20 having a distal anchor member 30,a proximal anchor member 40, and a connecting section 50 connecting aproximal end portion of the distal anchor member 30 to a distal endportion of the proximal anchor member 40.

[0041] The distal anchor member 30 is constructed to be moved from areduced profile position, shown in FIGS. 1 and 3, to a deployed(expanded) position, shown in FIGS. 6 and 7. The proximal anchor member40 is preferably constructed similar or identical to the distal anchormember 30. The proximal anchor member 40 is also movable from a reducedprofiled position shown in FIGS. 1 and 0.3, to a deployed (expanded)position, shown in FIGS. 6 and 7.

[0042] Preferably, the distal anchor member 30 and proximal anchormember 40 are constructed to move from their respective reduced profilepositions to their respective deployed positions in response to axialcompressive forces reducing the axial spacing between opposite endportions of the anchor members 30 and 40. In other words, the distalanchor member 30 is preferably constructed so that it expands to thedeployed position when a spacing between proximal and distal endportions of the distal anchor member 30 is reduced. Similarly, theproximal anchor member 40 is preferably constructed so that it expandsto the deployed position when a spacing between proximal and distal endportions of the proximal anchor member 40 is reduced.

[0043] The distal and proximal anchor members 30 and 40 are preferablymesh structures including individual filaments braided or woventogether. Preferably, the anchor members 30 and 40 are made ofexpandable, woven mesh material. For example, the anchor members 30 and40 are mesh structures having filaments formed at least in part of nylonmaterial. In the relaxed, reduced profile position shown in FIGS. 1 and3, the distal and proximal anchor members 30 and 40 have a generallycylindrical shape. In the expanded, deployed position, shown in FIGS. 6and 7, the distal and proximal anchor members 30 and 40 have a generallyannular disk shape.

[0044]FIG. 8 shows how the fastener 20 fastens tissue. The distal end ofthe fastener 20 is inserted in holes H1 and H2 formed in tissues layersT1 and T2, respectively, while the distal anchor member 30 is in thereduced profile position. Preferably, the connecting section 50 has alength sufficient to pass through both tissue layers T1 and T2. Thedistal anchor member 30 is deployed and placed against a surface of oneof the tissue layers T1, and the proximal anchor member 40 is deployedand placed against the surface of the other tissue layer T2. Thisfastens the tissue layers T1 and T2 together between the deployed anchormembers 30 and 40.

[0045] In an alternative construction of the fastener 20, a single pieceof mesh material forms both of the anchor members 30 and 40 and a layerof material coated on the mesh material between the anchor members 30and 40 forms the connecting section 50.

[0046] As shown in FIG. 5, a distal end portion of the distal anchormember 30 is connected to an outer surface of an elongated, tubularshaped, support member 52. The tubular support member 52 has an outerdiameter smaller than the inner diameter of the proximal anchor member40, the inner diameter of the connecting section 50, and the innerdiameter of the portion of the distal anchor member 30 that lacksconnection to the support member 52.

[0047] An actuator 54 is removably coupled to the support member 52 asshown in FIG. 5. The actuator 54 passes through a lumen of the supportmember 52 and through a proximal end portion of fastener 20. Theactuator 54 preferably includes a length of thread material (or wire)passing through a pair holes 56 a and 56 b in the support member 54 sothat a portion of the thread is positioned on an outer surface of thesupport member 52. Because the thread passes through the holes 56 a and56 b, the thread is capable of being removed from the support member 52and fastener 20 by pulling one end of the thread.

[0048] Proximal movement of the actuator 54 moves the support member 52proximally in the distal anchor member 30, in the connecting section 50,and in the proximal anchor member 40 when a distally directed pushingforce is applied at a proximal end of the fastener 20. Because thedistal end of the support member 52 is connected to the distal end ofthe distal anchor member 30, the proximal movement of the support member52 moves the distal end of the fastener 20 toward the proximal end ofthe fastener 20. Initially, the proximal movement of the support member52 reduces the spacing between the opposite ends of the distal anchormember 30 and further proximal movement of the support member 52eventually places the distal anchor member 30 in the deployed position.After the distal anchor 30 moves to the deployed position, the continuedproximal movement of the support member 52 reduces the spacing betweenopposite ends of the proximal anchor member 40 to place the proximalanchor member 40 also in the deployed position.

[0049] As shown in FIG. 5, a proximal end portion of the support member52 includes one or more retainers 58. Preferably, the retainers 58 areconfigured to engage a proximal end portion of the proximal anchormember 40, as shown in FIG. 7, so that the distal and proximal anchormembers 30 and 40 are retained in their deployed positions. In theembodiment shown in FIGS. 5 and 7, the retainers 58 are flaps ofresilient material extending from the outer surface of the supportmember 52 so that the retainers 58 engage a proximal end of the fastener20 after the support member 52 moves a sufficient distance out of anopening in the proximal end of the fastener 20. Alternatively, theretainers 58 could be other types of engagement mechanisms, such aslocking ribs or teeth.

[0050] The system 10 also includes structure for inserting the fastener20 and for deploying the anchor members 30 and 40. As shown in FIGS. 14,6, and 7, the system 10 includes a relatively flexible introducer tube60 and a relatively flexible pushing member 62 extending in theintroducer tube 60. A distal end portion of the introducer tube 60 hasan inner diameter sized to contain the fastener 20 therein, as shown inFIG. 1. The distal end of the introducer tube 60 has a sharp needle tip61 capable of puncturing the esophageal and gastric walls. A proximalend portion of the introducer tube 60, shown in FIGS. 2 and 4, has afirst connector 64 configured to be connected with a correspondingsecond connector 66 on the pushing member 62. In addition, the proximalend portion of the introducer tube 60 has a gripping member 65 allowinga physician to retract the introducer tuber 60 in the proximal directionafter the fastener 20 is within the gastric lumen.

[0051] The pushing member 62 is a tube axially movable in the lumen ofthe introducer tube 60. When the fastener 20 is introduced into the bodyof a patient, the fastener 20 is positioned in the distal end portion ofthe introducer tube 60 and the pushing member 62 is in a retractedposition, as shown in FIGS. 1 and 2, so that a distal end of the pushingmember 62 is spaced from the distal end of the introducer tube 60.

[0052] The distal end of the pushing member 62 has an opening with aninner diameter smaller than the outer diameter of the proximal endportion of the fastener 20. Distal movement of the pushing member 62with respect to the introducer tube 60 pushes the distal and proximalanchor members 30 and 40 through the distal opening in the introducertube 60, as shown in FIG. 3. When the pushing member 62 is in thisposition, the first connector 64 is capable of being connected to thesecond connector 66, as shown in FIG. 4.

[0053] The actuator 54 extends through a lumen in the pushing member 62and passes through an opening in the second connector 66. After thefirst connector 64 is connected to the second connector 66, the actuator54 is moved in the proximal direction. During proximal movement of theactuator 54, the distal end of pushing member 62 contacts the proximalend of the fastener 20 and applies a distally directed pushing force tolimit proximal movement of the fastener 20 in the introducer tube 60.The initial proximal movement of the actuator 54 moves the supportmember 52 in the fastener 20 to place the distal anchor member 30 in thedeployed position shown in FIG. 6. Continued proximal movement of theactuator 54 moves support member 52 further in the fastener 20 to placethe proximal anchor member 40 in the deployed position shown in FIG. 6.Eventually, the retainers 58 engage the proximal end of the fastener 20,as shown in FIG. 7, and limit distal movement of the support member 52in the fastener 20 to thereby retain the anchor members 30 and 40 in thedeployed positions.

[0054] When the retainers 52 have engaged the proximal end of thefastener 20, the introducer tube 60 and pushing member 62 are pulledaway from the fasten r 20, as shown in FIG. 7. In addition, the actuator54 is preferably uncoupled from the support member 52. For example, whenthe actuator 54 includes thread, one end of the thread is pulled to passthe other end of the thread through the holes 56 a and 56 b shown inFIG. 5.

[0055]FIGS. 9 and 10 show an alternative embodiment of a tissuefastening system 10 a. As shown in FIG. 9, the tissue fastening system10 a includes a fastener 20 a having a distal anchor member 30 aincluding a distal end portion 32 connected to an elongated supportmember 51 and a proximal end portion 34 slidably mounted on the supportmember 51. An axially movable actuator 54 a is provided in a lumen ofthe support member 51. The actuator 54 a has a distal end configured tocontact the slidable distal end portion 34 of the distal anchor member30 a.

[0056] The distal anchor member 30 a preferably has a mesh structuresimilar to the distal anchor member 30 of the system 10 shown in FIGS.1-7. The distal anchor member 30 a is moved from a reduced profileposition, illustrated with broken lines in FIG. 9, to a deployedposition, shown in FIG. 9, when the actuator 54 a is moved in the distaldirection to slide the proximal end portion 34 toward the distal endportion 32.

[0057] When the distal anchor member 30 a is deployed and the supportmember 51 passes through holes H1 and H2 formed in tissue layers T1 andT2, as shown in FIG. 10, positioning the distal anchor member 30 aagainst the tissue layer T1 maintains the distal anchor member 30 a inthe deployed position.

[0058] As shown in FIG. 10, the system 10 a also includes a proximalanchor member 40 a preferably having a mesh structure similar to theproximal anchor member 40 of the system 10 shown in FIGS. 1-7. Theproximal anchor member 40 a has a distal end portion 42 and a proximalend portion 44 both slidably mounted on the outer surface of the supportmember 51.

[0059] The system 10 a also includes a pushing member 62 a having adistal end with an opening having an inner diameter smaller than theinner diameter of the slidable proximal end portion 44. Distal movementof the pushing member 62 a slides the proximal and distal end portions44 and 42 against the tissue layer T2. Further distal movement of thepushing member 62 a places the proximal anchor member 40 a in a deployedposition similar to the deployed position of the distal anchor member 30a. When both the distal and proximal anchor members 30 a and 40 b aredeployed with the tissue layers T1 and T2 therebetween, the tissuelayers T1 and T2 are fastened to one another in a manner similar to thatshown in FIG. 8.

[0060] One or more retainers 58 a are provided on a proximal portion ofthe support 51. The retainers 58 a engage at least the proximal endportion 44 during sliding of the proximal end portion 44 to retain theproximal anchor member 40 in the deployed position. Preferably, theretainers 58 a are locking teeth or ribs allowing for a “racheting”adjustment of the location of the engagement along the support 51.

[0061] During the deployment of both the distal and proximal anchormembers 30 a and 40 a, structure, such as the pushing member 62 shown inFIGS. 1 and 2, is preferably provided to limit distal movement of thesupport 51. In addition, the system 10 a preferably includes anintroducer tube, such as the introducer tube 60 of the system 10 shownin FIGS. 1-7.

[0062]FIG. 11 shows an embodiment of a system 10 b constructed similarto the system 10 a shown in FIGS. 9 and 10. The system 10 b includes adistal anchor member 30 b having a distal end portion 36 slidablymounted on an elongated support 51 b and a proximal end portion 38connected to the support 51 b. An actuator 54 b having a distal endconnected to the slidable distal end portion 36 is axially movable in alumen of the support 51 b.

[0063] Distal movement of the actuator 54 b moves the distal anchormember 30 b from a reduced profile position, illustrated with brokenlines in FIG. 11, to a deployed position, shown in FIG. 11. Preferably,the system 10 b includes retainers (not shown) for retaining the distalanchor member in the deployed position. In addition, the system 10 balso includes an introducer tube similar to the introducer tube 60 ofthe system 10 shown in FIGS. 1-7 and a proximal anchor member andpushing member similar to those of the system 10 a of FIGS. 10 and 11.

[0064] Methods of treating GERD are discussed below with reference toFIGS. 1-14 Although the invention is described in connection with thestructure shown in these figures, and in connection with treating GERD,it should be understood that the invention in its broadest sense is notso limited.

[0065] As shown in FIG. 12, an endoscope 70 is passed transorally(through the mouth of a patient) into the esophagus E until a distal endof the endoscope 70 is located adjacent to the junction J between thestomach S and the esophagus E. The endoscope 70 is preferably configuredto allow a physician to visualize the wall of the esophagus EW. To viewthe gastric wall GW (the stomach wall), conventional radiographic orultrasonic imaging equipment is also preferably used.

[0066] When the distal end of the endoscope 70 is properly positioned, aflexible piercing member 72, such as a needle, is introduced through theendoscope 70 and moved distally to pierce a hole H3 in the wall of theesophagus EW and a hole H4 in the gastric wall GW. During formation ofthe holes H3 and H4, conventional imaging equipment is preferably usedto properly position the piercing member 72.

[0067]FIG. 15 shows an alternate embodiment of an endoscope 70 a capableof being used in a GERD treatment procedure. As shown in FIG. 15, theendoscope 70 a has a first channel 80 for the piercing member 72 and asecond channel 82 for a tissue grasper 84 having a pair jaws. The tissuegrasper 84 is preferably used to pull the gastric wall GW toward thewall of the esophagus EW to facilitate forming the holes H3 and H4 withthe piercing member 72. Because the grasper 84 passes through thechannel 82 of the endoscope 70, the use of the grasper 84 does notrequire forming a percutaneous puncture or incision in the body of thepatient.

[0068] As shown in FIG. 12, the piercing member 72 preferably has one ormore outlets 73 positioned on a distal end portion of the piercingmember 72. The outlets 73 permit dispersal of an adhesion inducing agentinto the space between the esophageal wall EW and gastric wall GW bypassing the agent through a lumen in the piercing member 72 and throughthe outlets 73. Dispersing the adhesion inducing agent between theesophageal wall EW and gastric wall GE aids in holding these walls EWand GW together when anchor members 30 c and 40 c of the fastener 20 care deployed as shown in FIG. 14. Any type of conventional tissueadhesive could be used for the adhesion inducing agent. For example, thetissue adhesion agent is talc slurry, gel slurry, fibrin glue, sodiummorrhuate, or other bonding agent.

[0069] As those skilled in the art would recognize, the fastener 20 cacts as a tissue clamp to hold the esophageal wall EW and gastric wallGE together while the adhesion inducing agent cures or interacts withthese body tissue layers to fasten them together. In an alternativeembodiment, the fastener 20 c is formed a materials capable of degradingin the body after the adhesion inducing agent has formed a sufficientbond between the tissue layers.

[0070] After the piercing member 72 forms the holes H3 and H4, thepiercing member 72 is removed and a fastener 20 c shown in FIG. 13 isinserted transorally through the esophagus E via a lumen in theendoscope 70. Preferably, the fastener 20 c is constructed like one ofthe fasteners 20, 20 a, and 20 b described above and has distal andproximal anchor members 30 c and 40 c shown in FIG. 14. A distal end ofthe fastener 20 c is inserted through the holes H3 and H4 until thedistal anchor member 30 c is positioned in the stomach S. During theinsertion of the fastener 20 c through the esophagus E and the holes H3and H4, the distal and proximal anchor members 30 c and 40 c arepreferably in their reduced profile positions. In addition, the fastener20 c is preferably inserted while the fastener 20 c is in an introducertube 60 c shown in FIG. 13. The introducer tube 60 c is preferablyconstructed like the introducer tube 60 shown in the system of FIGS.1-7.

[0071] In one of the preferred methods according to the invention, thepiercing member 72 is not used to form the holes H3 and H4. Rather, thesharp distal end 61 of the introducer tube 60 shown in FIG. 1 is used toform the holes H3 and H4. Using the introducer 60 to form the holes H3and H4 allows the introducer 60 to be inserted while the fastener 20 cis in the introducer 60. This positions the fastener 20 c in the holesH3 and H4 immediately after the holes H3 and H4 are formed. Optionally,the distal end portion of the introducer 60 includes one or more outlets(not shown) similar to the outlets 73, shown in FIG. 12, to permitdispersal of the adhesion inducing agent between the esophageal wall EWand gastric wall GW.

[0072] After a physician uses the introducer 60 or 60 c to position thedistal anchor member 30 c in the stomach S, the distal anchor member 30c is placed in the deployed position, as shown in FIG. 13. The way inwhich the distal anchor member 30 c is placed in the deployed positiondepends on the particular design of the fastener 20 c. If the fastener20 c is constructed like the fastener 20 shown in FIGS. 1, 3, and 5-7,the distal anchor member 30 c is placed in the deployed position bypositioning the pushing member 62 shown in FIGS. 1-4, 6, and 7 against aproximal end of the fastener 20 c and pulling the actuator 54proximally. When the fastener 20 c is constructed like the fastener 20 ashown in FIGS. 9 and 10, the distal anchor member 30 c is placed in thedeployed position by moving the actuator 54 a in the distal direction toslide a proximal end of the anchor member 30 c toward a distal end ofthe anchor member 30 c. If the fastener 20 c is constructed like thefastener 20 b shown in FIG. 11, the distal anchor member 30 c isdeployed by moving the actuator 54 b in the proximal direction to slidea distal end of the anchor member 30 c toward a proximal end of theanchor member 30 c.

[0073] After the distal anchor member 30 c is deployed, the fastener 20c is optionally pulled in the proximal direction to position the gastricwall GW against the wall of the esophagus EW. For example, when thefastener 70 c is constructed like the fastener 20 shown in FIG. 1, thefastener 20 c is pulled proximally by applying a proximal pulling forceto the actuator 54 shown in FIGS. 1 and 2. Thereafter, the proximalanchor member 40 c is placed in a deployed position as shown in FIG. 14.The way in which the proximal anchor member 40 c is placed in thedeployed position also depends on the particular design of the fastener20 c. When the fastener 20 c is constructed like the fastener 20 shownin FIGS. 1, 3, and 5-7, the proximal anchor member 40 c is placed in thedeployed position by continued pulling of the actuator 54 in theproximal direction. When the proximal anchor member 40 c is constructedlike the proximal anchor member 40 a shown in FIG. 10, the proximalanchor member 40 c is deployed by pushing the pushing member 62 a toslide proximal and distal ends of the proximal anchor member 40 c towardthe wall of the esophagus EW.

[0074] After the distal and proximal anchor members 30 c and 40 c aredeployed, they are preferably retained in this deployed position. Forexample, the retainers 58 shown in FIGS. 5 and 7 or the retainers 58 ashown in FIG. 10 are provided on the fastener 20 c.

[0075] When the fastener 20 c is implanted as shown in FIG. 14,components such as the endoscope 70, the introducer tube 60 c, and anyactuators or pushing members are removed from the patient. Preferably,additional fasteners are also implanted to secure the stomach S to thelower esophagus E at a plurality of locations. Eventually, the stomach Sbecomes partially wrapped on the esophagus E so that the stomach S andesophagus E are positioned similar to the way in which they would bepositioned after a Nissen fundoplication procedure. As internal pressureof the stomach S increases during digestion, the stomach S applies acompressive force to the esophagus E that tends to reduce the innerluminal diameter of the esophagus E. This compressive force reduces thelikelihood of the stomach contents being able to pass through theesophagus E. In other words, the lower esophagus functions like aproperly functioning lower esophageal sphincter.

[0076]FIG. 16 shows another embodiment of a fastener 20 d according tothe present invention. The fastener 20 d includes an elongated body 100having an internal lumen 104. An inflatable balloon 106 is mounted onthe distal end portion of the body 100. The balloon 106 is formed ofeither an inelastic or elastic material. One or more apertures 108 onthe distal end portion of the body 100 place the interior of the balloon106 in fluid communication with the internal lumen 104.

[0077] A seal 110 in the lumen 104 prevents an inflating fluid, such asair, from escaping from the interior of the balloon 106 and from thedistal end portion of the lumen 104. As explained below, the seal 110 isconfigured to permit the inflating fluid to enter both the distal endportion of the lumen 104 and the balloon 106 via an inflating tube 118,shown in FIG. 18, passed through the seal 110. Preferably, the seal 110is a resilient flap of material capable of sealing inflation fluid inthe distal end portion of the body 100 and in the balloon 106 when theinflating tube 118 is withdrawn from the seal 110. Alternatively, theseal 110 is a slit valve or any other type of valve capable of sealingthe lumen 104 and permitting passage of the inflating tube 118 throughthe seal 110. In addition, the seal 110 could be a one-way valve, suchas a slit valve, capable of permitting passage of the inflating fluid inonly one direction in the lumen 104 without the need to pass theinflating tube 118 through the seal 110. For example, the seal could bea one-way slit valve positioned over the apertures 108.

[0078] As shown in FIG. 16, the fastener 20 d further includes a capmember 112. Preferably, the cap member 112 is a low profile, disc-shapedplate having an opening 114 allowing the cap member 112 to fit slidablyon the proximal end portion of the elongated body 100. Retainers 116,such as locking ribs, teeth or resilient flaps, are provided on theproximal end portion of the body 100 to retain the cap member 112 on thebody 100.

[0079] FIGS. 17-20 show how the fastener 20 d shown in FIG. 16 is usedto treat GERD. As shown in FIG. 17, an endoscope 70 is positioned in theesophagus E transorally until the distal end of the endoscope 70 is nearthe junction J of the esophagus E and the stomach S. Thereafter, anintroducer 60 d, preferably constructed like the introducer 60 shown inFIG. 1, is inserted in the endoscope 70 and through the esophageal andgastric walls EW and GW to form a hole H3 in the esophageal wall EW anda hole H4 in the gastric wall GW. Preferably, the fastener 20 d isplaced in a lumen of the introducer 60 when the introducer 60 forms theholes H3 and H4 so that the balloon 106 ends up in the stomach S.

[0080] Then, the introducer 60 is retracted in the proximal directionand the balloon 106 is inflated while the balloon 106 is positioned inthe stomach S, as shown in FIG. 18. To inflate the balloon 106, theinflation tube 118 is inserted in the endoscope 70 and passed throughthe seal 110. Fluid, such as air, flowing through the inflating tube 118passes into the interior of the balloon 106 via the lumen 104 andapertures 108. When the balloon 106 is inflated, the balloon 106preferably assumes a low-profile, generally disc shape in the stomach S.

[0081] While the balloon 106 is maintained in the inflated condition,the cap member 112 is advanced toward the fastener 20 d, as shown inFIG. 19, by placing the inflating tube 118 in the opening 114 of the capmember 112 and pushing the cap member 112 toward the fastener 20 d withpushing tube 120 having an inner lumen capable of sliding along theouter surface of the inflating tube 118. Continued pushing of the capmember 112 with the pushing tube 120 slides the cap member 112 on thebody 100 and the retainers 116 retain the cap member 112 on the body100. This sandwiches the esophageal wall EW and gastric wall GW togetherbetween the cap member 112 and inflated balloon 106, as shown in FIG.20.

[0082] Thereafter, the inflating tube 118, pushing tube 120, andendoscope 70 are removed from the esophagus E. As the inflating tube 118passes out of the seal 110, the seals 110 closes to trap the inflatingfluid in the balloon 106 and thereby maintain the inflation of theballoon 106. As shown in FIG. 20, the fastener 20 d fastens the gastricwall GW to the esophageal wall EW in a manner similar to the fastener 20c shown in FIG. 14.

[0083] Preferably, the fastener according to the invention does notextend an excess distance into the esophagus E and does notsignificantly interfere with normal digestion. In particular, thefastener preferably has a low profile and lacks rough or sharp edges.The portion of the fastener passing through the holes formed in thtissue preferably has a sufficient cross-sectional size to resisttearing or cutting of tissue. In addition, the fastener is preferablymade of materials capable of being implanted for extended periods oftime.

[0084] Preferably also, the fastener according to the invention iscapable of being implanted using patient sedation without generalanesthesia. If additional tissue holding force is required, multiplefasteners according the invention could be used to fasten the tissuelayers together. In addition, the size of the fastener could be variedto treat pediatric or neo-natal patients. Because the fastener isrelatively small even when it is used to treat adult patients, thefastener is capable of passing through the digestive tract withoutcausing traumatic injury, if extreme esophageal gastric movements pullthe fastener through the tissue layers.

[0085] Although the fastener according to the invention is preferablyused to fasten the wall of the esophagus to the gastric wall in a GERDtreatment procedure, the fastener could be used to fasten differentlayers of body tissue in different types of procedures. For example, thefastener could be used to fasten more than two layers of tissuetogether.

[0086] It will be apparent to those skilled in the art that variousmodifications and variations can be made to the structure andmethodology of the present invention without departing from the scope orspirit of the invention. In view of the foregoing, it is intended thatthe present invention cover modifications and variations of thisinvention provided they fall within the scope of the following claimsand their equivalents.

What is claimed is:
 1. An implantable fastener for fastening layers oftissue together, comprising: an elongated support; a distal anchormember having a first end portion connected to the support and a secondend portion movable on the support, the distal anchor member beingconfigured to be movable from a reduced profile position to a deployedposition when a spacing between the first and second end portions isreduced; a proximal anchor member having first and second end portionsmovable on the support, the proximal anchor member being configured tobe movable from a reduced profile position to a deployed position when aspacing between the first and second end portions of the proximal anchormember is reduced, the proximal anchor member being spaced from thedistal anchor member a distance sufficient to position the layers oftissue together between the proximal and distal anchor members; and atleast one retainer on a proximal end portion of the support, theretainer engaging one of the end portions of the proximal anchor memberwhen at least the proximal anchor member is in the deployed position. 2.The implantable fastener of claim 1, wherein each of the distal andproximal anchor members includes an expandable mesh structure having agenerally cylindrical shape in the reduced profile position and agenerally disk shape in the deployed position.
 3. The implantablefastener of claim 1, wherein the first end portion of the distal anchormember is a distal end portion and wherein the implantable fastenerfurther includes a connecting section connecting a proximal end of thedistal anchor member to a distal end of the proximal anchor member, theconnecting section being movable on the elongated support and having alength sufficient to place the layers of tissue together between theproximal and distal anchor members.
 4. The implantable fastener of claim3, wherein the retainer is located on the support so that the retainerengages a proximal end portion of the proximal anchor member to retainthe proximal anchor member and the distal anchor member in the deployedpositions.
 5. The implantable fastener of claim 1, wherein the first endportion of the distal anchor member is a distal end portion and whereinthe second end portion of the distal anchor member is slidably mountedon the support.
 6. The implantable fastener of claim 1, wherein thefirst end portion of the distal anchor member is a proximal end portionand wherein the second portion of the distal anchor member is slidablymounted on the support.
 7. The implantable fastener of claim 1, whereinthe first and second end portions of the proximal anchor member areslidably mounted on the support, and wherein the retainer is located onthe support so that the retainer engages a proximal end portion of theproximal anchor member to retain the proximal anchor member in thedeployed position.
 8. A system for fastening layers of body tissuetogether, comprising: the implantable fastener of claim 5, the fastenerfurther including a lumen in the support; and a pushing member extendingin the lumen of the support, a distal end of the pushing member beingconfigured to contact the second end portion of the distal anchor memberso that distal movement of the pushing member slides the second endportion of the distal anchor member toward the first end portion of thedistal anchor member to place the distal anchor member in the deployedposition.
 9. A system for fastening layers of body tissue together,comprising: the implantable fastener of claim 6, the fastener furtherincluding a lumen in the support; and an actuator extending in the lumenof the support, the actuator being coupled to the second end portion ofthe distal anchor member so that proximal movement of the actuatorslides the second end portion of the distal anchor member toward thefirst end portion of the distal anchor member to place the distal anchormember in the deployed position.
 10. A system for fastening layers ofbody tissue together, comprising: the implantable fastener of claim 7;and a pushing member having a distal end configured to contact theproximal end portion of the proximal anchor member so that distalmovement of the pushing member slides the proximal end portion of theproximal anchor member toward a distal end portion of the proximalanchor member to place the proximal anchor member in the deployedposition.
 11. An implantable fastener for fastening layers of tissuetogether, comprising: a first anchor member having a distal end portionand a proximal end portion, the first anchor member being configured tobe movable from a reduced profile position to a deployed position when aspacing between the proximal and distal end portions is reduced; asecond anchor member having a proximal end portion and a distal endportion, the second anchor member being configured to be movable from areduced profile position to a deployed position when a spacing betweenthe proximal and distal end portions of the second anchor member isreduced; a connecting section connecting the proximal end portion of thefirst anchor member to the distal end portion of the second anchormember, the connecting section having a length sufficient to positionthe layers of tissue together between the first and second anchormembers; an elongated support connected to the distal end portion of thefirst anchor member, the support being movable proximally in theproximal end portion of the first anchor member, in the connectingsection, and in the second anchor member to place the first and secondanchor members in the deployed positions; and at least one retainer on aproximal end portion of the support, the retainer engaging the proximalend portion of the second anchor member when the first and second anchormembers are in the deployed positions.
 12. The implantable fastener ofclaim 11, wherein each of the first and second anchor members includesan expandable mesh structure having a generally cylindrical shape in thereduced profile position and a generally disk shape in the deployedposition.
 13. A system for fastening layers of body tissue together,comprising: the implantable fastener of claim 11; an introducer tubehaving a lumen, the implantable fastener being capable of being placedin the lumen of the introducer tube when the first and second anchormembers are in the reduced profile position; a pushing member extendingin the lumen of the introducer tube, a distal end of the pushing memberbeing configured to contact a proximal end of the fastener; and anactuator extending through the introducer tube, the actuator beingcoupled to the elongated support so that proximal movement of theactuator moves the support proximally in the proximal end portion of thefirst anchor member, in the connecting section, and in the second anchormember when the distal end of the pushing member contacts the proximalend of the fastener.
 14. The system of claim 13, wherein the pushingmember includes a lumen and wherein the actuator passes through thelumen of the pushing member.
 15. The system of claim 13, wherein theactuator includes a thread removably coupled to the elongated support.16. The system of claim 13, further comprising a first connector on aproximal end of the introducer and a second connector on a proximal endof the pushing member, the first connector being adapted to be connectedto the second connector.
 17. The system of claim 13, wherein a distalend of the introducer has a sharp tip capable of piercing the layers oftissue.
 18. The system of claim 13, wherein a distal end portion of theintroducer has at least one outlet for permitting an adhesion inducingagent to be introduced between the layers of tissue.
 19. The system ofclaim 13, further comprising a piercing member configured to pierce thetissue layers.
 20. The system of claim 19, wherein the piercing memberincludes at least one outlet for permitting an adhesion inducing agentto be introduced between the tissue layers.
 21. An implantable fastenerfor fastening layers of tissue together, comprising: an elongated bodyhaving a lumen and at least one aperture in a distal end portion of thebody; a balloon on the distal end portion of the body, an interior ofthe balloon being flow connected to the lumen of the body via theaperture so that the balloon is capable of being inflatable from areduced profile position to an inflatable position; a seal on the bodyto maintain inflating fluid in the balloon; a cap member configured tobe positioned on a proximal end of the body; and at least one retaineron the proximal end portion of the body for retaining the cap member onthe body when the tissue layers are between the balloon and the capmember.
 22. The fastener of claim 21, wherein the seal is configured topermit passage of an inflating tube through the seal.
 23. The fastenerof claim 21, wherein the balloon has a low profile, generally disc shapewhen the balloon is in the inflated position.
 24. The fastener of claim21, wherein the cap member has an opening permitting sliding of the capmember on the proximal end portion of the fastener.
 25. A system forfastening layers of tissue together, comprising: the fastener of claim21; and an inflating tube for passing inflating fluid into the balloon.26. The system of claim 25, further comprising a pushing member forpushing the cap member on the proximal end portion of the body.
 27. Thesystem of claim 21, further comprising an introducer tube having a sharpend configured to pierce the tissue layers.
 28. A method of treatinggastroesophageal reflux disease using at least one implantable fastenerincluding a distal anchor member configured to be movable from a reducedprofile position to a deployed position, and a proximal anchor memberconfigured to be movable from a reduced profile position to a deployedposition, comprising: passing the implantable fastener transorallythrough the esophagus to a position near the junction between theesophagus and the stomach; inserting the distal anchor member through ahole formed in the wall of the esophagus and through a hole formed inthe gastric wall while the distal anchor member is in the reducedprofile position; placing the distal anchor member in the deployedposition; and placing the proximal anchor member in the deployedposition to fasten the wall of the esophagus and the gastric walltogether between the deployed distal anchor member and the deployedproximal anchor member.
 29. The method of claim 28, further comprisingforming the hole in the wall of the esophagus and forming the hole inthe gastric wall by piercing the wall of the esophagus and the gastricwall.
 30. The method of claim 28, further comprising introducing anadhesion inducing agent between the wall of the esophagus and thegastric wall.
 31. The method of claim 28, wherein the distal anchormember is configured to be placed in the deployed position by reducing aspacing between proximal and distal end portions of the distal anchormember and wherein the proximal anchor member is configured to be placedin the deployed by reducing a spacing between proximal and distal endportions of the proximal anchor member, the placing of the distal anchormember in the deployed position including reducing the spacing betweenthe proximal and distal end portions of the distal anchor member, andthe placing of the proximal anchor member in the deployed positionincluding reducing the spacing between the proximal and distal endportions of the proximal anchor member.
 32. The method of claim 28,further comprising retaining the distal anchor member and the proximalanchor member in the deployed positions while the wall of the esophagusand the gastric wall are between the deployed distal anchor member andthe deployed proximal anchor member.
 33. The method of claim 28, whereinthe placing of the distal anchor member in the deployed position and theplacing of the proximal anchor in the deployed position include placinga pushing member against a proximal end of the implantable fastener andpulling an actuator proximally to move a distal end of the fastenertoward a proximal end of the fastener.
 34. The method of claim 28,wherein the placing of the distal anchor member in the deployed positionincludes pushing a proximal end portion of the distal anchor membertoward a distal end portion of the distal anchor member.
 35. The methodof claim 28, wherein the placing of the distal anchor member in thedeployed position includes pulling a distal end portion of the distalanchor member toward a proximal end of the distal anchor member.
 36. Themethod of claim 28, wherein the placing of the proximal anchor member inthe deployed position includes moving proximal and distal end portionsof the proximal anchor member toward the wall of the esophagus.
 37. Amethod of treating gastroesophageal reflux disease using a fastenerincluding an elongated body, a balloon on the body, and a cap member,the method comprising: passing the fastener transorally through theesophagus to a position near the junction between the esophagus and thestomach; inserting the balloon through a hole formed in the wall of theesophagus and a hole formed in the gastric wall while the balloon is ina reduced profile position; inflating the balloon; and retaining the capmember on the body of the fastener to fasten the wall of the esophagusand the gastric wall together between the cap member and the inflatedballoon.
 38. The method of claim 37, further comprising forming the holein the wall of the esophagus and forming the hole in the gastric wall bypiercing the wall of the esophagus and the gastric wall.
 39. A method offastening at least two layers of tissue together, comprising:introducing an adhesion inducing agent between first and second tissuelayers in a body; inserting an implantable fastener in the body; andholding the first and second tissue layers together with the implantablefastener while the adhesion inducing agent is between the first andsecond tissue layers.
 40. The method of claim 39, wherein the firstlayer of tissue is the wall of the esophagus and the second layer oftissue is the gastric wall.
 41. The method of claim 39, furthercomprising: forming a first hole in the first tissue layer and a secondhole in the second tissue layer, and passing the fastener through thefirst and second holes.
 42. The method of claim 41, wherein theimplantable fastener includes a proximal anchor member and a distalanchor member, and wherein the holding includes placing the anchormembers in a deployed position to sandwich the tissue layers between theanchor members.